Method for iontophoretic delivery of antiviral agents

ABSTRACT

A portable iontophoresis apparatus for facilitating delivery of medication across the cutaneous membrane into adjacent underlying tissues and blood vessels. The apparatus employs a modular, detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The apparatus is designed to be hand-held and includes a circumferential tactile electrode band on the base assembly which provides electrical connection between the skin of the user&#39;s hand and one pole of a bipolar power source housed within the base assembly. The opposing pole of the power source is connected to the applicator electrode. The user&#39;s body completes the electrical circuit between the applicator and tactile electrodes. A method for using the device for the treatment of Herpes simplex infection and related viral infections which produce similar cutaneous lesions is presented. The apparatus, when used in accordance with the method described herein, demonstrated &gt;90% treatment efficacy in clinical trials.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of application Ser. No.08/868,499 filed Jun. 4, 1997, now U.S. Pat. No. 5,879,323 issued Mar.9, 1999, which is a divisional of allowed U.S. patent application Ser.No. 08/646,853 filed May 8, 1996 now U.S. Pat. No. 5,767,648.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to the transdermal electrokinetic masstransfer of medication into a diseased tissue, and, more specifically,to a portable apparatus for the iontophoretic delivery of medicationacross the skin and incorporation of the medication into diseasedtissues and blood vessels adjacent to the delivery site. The apparatusprovides a new method for treating and managing diseases presentingcutaneous lesions.

2. Prior Art

Iontophoresis has been employed for several centuries as a means forapplying medication locally through a patient's skin and for deliveringmedicaments to the eyes and ears. The application of an electric fieldto the skin is known to greatly enhance the skin's permeability tovarious ionic agents. The use of iontophoretic transdermal deliverytechniques has obviated the need for hypodermic injection for manymedicaments, thereby eliminating the concomitant problems of trauma,pain and risk of infection to the patient.

Iontophoresis involves the application of an electromotive force todrive or repel oppositely charged ions through the dermal layers into atarget tissue. Particularly suitable target tissue include tissuesadjacent to the delivery site for localized treatment or tissues remotetherefrom in which case the medicament enters into the circulatorysystem and is transported to a tissue by the blood. Positively chargedions are driven into the skin at an anode while negatively charged ionsare driven into the skin at a cathode. Studies have shown increased skinpenetration of drugs at anodic or cathodic electrodes regardless of thepredominant molecular ionic charge on the drug. This effect is medicatedby polarization and osmotic effects.

Regardless of the charge of the medicament to be administered, aiontophoretic delivery device employs two electrodes (an anode and acathode) in conjunction with the patient's skin to form a closed circuitbetween one of the electrodes (referred to herein alternatively as a"working" or "application" or "applicator" electrode) which ispositioned at the delivered site of drug delivery and a passive or"grounding" electrode affixed to a second site on the skin to enhancethe rate of penetration of the medicament into the skin adjacent to theapplicator electrode.

Recent interest in the use of iontophoresis for delivering drugs througha patient's skin to a desired treatment site has stimulated a redesignof many of such drugs with concomitant increased efficacy of the drugswhen delivered transdermally. As iontophoretic delivery of medicamentsbecome more widely used, the opportunity for a consumer/patient toiontophoretically administer a transdermal dosage of medicaments simplyand safely at non-medical or non-professional facilities would bedesirable and practical. Similarly, when a consumer/patient travels, itwould be desirable to have a personal, easily transportable apparatusavailable which is operable for the iontophoretic transdermal deliveryof a medication packaged in a single dosage applicator. The presentinvention provides a portable iontophoretic medicament deliveryapparatus and a unit-dosage medicament-containing applicator electrodewhich is disposable and adapted for use with the apparatus forself-administering medicament.

SUMMARY OF THE INVENTION

The present invention discloses a portable iontophoretic transdermal ortransmucoscal medicament delivery apparatus and a unit dosage medicamentapplicator electrode adapted for use with the apparatus for theself-administration of a unit dose of a medicament into the skin. Theapparatus is particularly suited for the localized treatment of herpesinfections. Recurrent herpetic infections (fever blisters or herpeslabialis) are very common and usually involve the mucocutaneousjuncture. The established treatment for recurrent herpetic lesions (oralor genital) has been primarily supportive; including local topicalapplication of anesthesia. Severe cases have been treated with systemicAcyclovir® (Zovirax Burroughs-Wellcome). Some cases the condition ismanaged with prophylactic long-term dosing administration with asuitable antiviral agent at great expense. Systemic treatment of acuteherpetic flare-ups may reduce the normal 10-12 day course of cutaneoussymptoms into a 6-8 day episode. Topical treatment of lesions withAcyclovir® has not been as effective as in vitro studies would suggest.A compound which is not presently available to clinicians but hasdemonstrated significant anti herpetic activity is 5-iodo-2 deoxyuridine(IUDR). Both of those agents have shown limited clinical efficacy whenapplied topically to the herpetic lesion. It is the present inventor'scontention that the limited efficacy of topical administrationpreviously observed is, at least in part, due to the poor skinpenetration of these medicaments when applied topically. The presentinvention provides improved transdermal delivery of these medicamentsand demonstrates improved clinical results in the case of Herpes.

Oral Herpes (most commonly Herpes simplex I infection) as well asgenital Herpes (usually Herpes Simplex II infection) afflict manypeople, cause discomfort, shame, and may contribute to more severe andcostly illnesses such as cervical cancer, prostate cancer, and perinatalblindness from herpetic conjunctivitis. The present invention disclosesa portable, user-friendly transdermal delivery device and a method forusing the device with Acyclovir® (or similar antiviral agent) to greatlybenefit these afflicted patients. The present inventor has constructedembodiments of this device and conducted human clinical trials whichclearly demonstrate improved therapeutic efficacy usingiontophoretically administered antiviral agents when compared tounassisted topical application of the agent.

It is an object of the present invention to provide an iontophoreticmedicament delivery apparatus which is portable and operable forself-administration of medicament into the skin of a person.

It is another object of the present invention to provide an improvediontophoretic transdermal drug delivery apparatus having amedicament-containing application electrode which disperses a singledosage and is disposable and non-reusable.

It is a feature of the present invention that the iontophoreticmedicament delivery apparatus is easily maneuverable and operable whenhand-held.

It is another feature of the present invention that the iontophoreticmedicament delivery apparatus is battery powered and convenientlytransported by a person.

It is a further feature of the present invention that the iontophoreticmedicament delivery apparatus employs a tactile electrode which is inelectrical contact with the skin of a user's hand when the apparatus isheld in the user's hand, obviating the need for a separate groundingelectrode connector or wire.

It is still another feature of the present invention that theiontophoretic medicament delivery apparatus is adapted to be operablewith a disposable medicament containing applicator electrode whichapplicator electrode includes an absorbent, inert, non-corrosive portioncontaining a therapeutic agent.

It is yet another feature of the present invention to provide anembodiment of an iontophoretic transdermal delivery device wherein thedisposable iontophoretic medicament-containing applicator electrode isadapted for releasable attachment to use with a hand-held base assemblyhousing a grounding electrode.

It is yet another feature of the present invention that the disposableiontophoretic medicament applicator electrode include indicator meansoperable for enabling a user to determine when the medicament within theremovable applicator electrode has been released in delivery and/ordepleted.

It is yet another feature of the present invention that the circuitryemployed in the disposable iontophoretic medicament applicator includecurrent limiting means operable for limiting the electrical currentflowing between the surface of the applicator and the skin to less thanabout one milliampere per square centimeters of application electrodeskin-contacting, surface.

It is another advantage of the present invention that the iontophoreticmedicament delivery apparatus employs a disposable application electrodewhich conducts the electrical current to the tissue through the solutionin which the medicament is dissolved.

It is still another advantage of the present invention that the improveddisposable iontophoretic medicament applicator is inexpensive, safe touse, substantially unitary in construction and greatly increases thetherapeutic efficacy of a medicament administered thereby.

The apparatus in accordance with the present invention provides a meansfor topically administering medicament directly and with, highefficiency into a diseased tissue thereby providing a novel method fortreating clinical conditions presenting mucocutaneous symptoms andparticularly mucocutaneous Herpes Simplex viral eruptions and sequelleassociated therewith.

In one embodiment the electrode comprises a unitary flexible strip (suchas SILASTIC®- by Dow Corning) having perforations dimensioned toaccommodate a medicament placed therein. The perforations or "cells" canbe made to store and dispense gels, ointments, fluids and othermedicament vehicles without requiring the reformulation of the eitherthe medicament or the vehicle.

The above objects, features and advantages of the invention are realizedby the improved monopolar iontophoretic, medicament applicator which iseasily transportable. The applicator employs a detachable medicamentcontaining application electrode. The objects, features and advantagesof the invention will become apparent upon consideration of thefollowing detailed disclosure of the invention, especially when it istaken in conjunction with the accompanying drawings wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational plan view of the iontophoretic medicamentdelivery apparatus showing the circumferential tactile ground electrodeon the outer surface of the base housing and a disposable iontophoreticapplication electrode;

FIG. 2 is a side elevational view of the disposable non-reusableiontophoretic application electrode with a portion broken away to viewthe medicament dose packet;

FIG. 3 is a top view of a medicament dispensing electrode adapted foruse with an iontophoresis handpiece.

FIG. 4 is a side elevational exploded view of the medicament dispensingelectrode of FIG. 3.

FIG. 5 is a perspective view illustrating the medicament dispensingelectrode of FIGS. 3 and 4 attached to an iontophoresis handpiece inpreparation for use.

FIG. 6 is a perspective view illustrating a patient preparing toself-administer medicament to lesions adjacent to the mouth employingthe iontophoretic electrode/handpiece delivery system in accordance withthe present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 shows, in side elevation, a preferred embodiment of the hand-heldiontophoretic transdermal medicament delivery apparatus of the presentinvention. The apparatus, indicated generally by the numeral 10, has anelongate base assembly 11 the major portion of which is preferablyformed of plastic and shaped to conform to and comfortably fit within ausers hand. An applicator electrode module 12, containing a unit dose ofmedicament 23, is releasably attached to a applicator electrodereceptacle 14 on the distal end of the base assembly 11. The applicationelectrode 12 is preferably a "clip-on" type of electrode similar inconfiguration to an electrocardiogram electrode. In the drawingpresented in FIGS. 1 and 2, electrically conductive elements such aswires and busses are presented as heavy lines. A wire 16 provideselectrical connection between the applicator electrode receptacle 14 andwire 1 within the neck 15 of the base assembly 11. Connecting wire 18,in turn, provides electrical connection between the wire 16 and thecurrent driver unit 19 housed within the base assembly 11. A conductivetactile electrode 20 forms a portion of the exterior skin-contactingsurface of the base assembly 11 preferably circumferentially enclosing aportion of the base housing or it may be interrupted or discontinuous onthe outer surface. The tactile electrode 20 is in electricalcommunication with the cathode 24C of battery 24 by means of a buss 17and conductive urging spring 25 which secures the battery in positionwithin the base assembly 11. For the self-administration of medicament auser must have. skin contact with the tactile electrode 20 for the unitto operate. Current driver 19 underlies the cathodic (ground) tactileelectrode 20 and is electrically connected via wire 21 to a voltagemultiplier 22. The voltage multiplier 22 receives low voltage power fromthe anode 24a of the battery power source 24 and increases the availablevoltage for presentation to the application electrode 12. The battery 24is preferably a size AA or AAA. Battery 24 is held in place by anelectrically conductive biasing spring 25 and ensures that electricalpower is available at the application electrode 12 when the user graspsand holds the base housing 11 of the apparatus 10 thereby touching thecathodic tactile electrode 20. The application electrode 12 and thetactile electrode 20 thus form a closed circuit in series with theuser's skin.

When current flows across the user's skin to the application electrodein response to an applied voltage the current promotes and hastens thepenetration of the medicament 23 contained in a reservoir 26 within theworking electrode 12 into the skin. The polarity of the workingelectrode 12 is preferably unidirectional to promote the above describedpenetration without requiring a separate grounding electrode. Theworking application electrode 12 will be described in greater detailbelow.

The base assembly 11 of apparatus 10 serves as a housing to theaforesaid components as a handle. The portion of the base assembly 11exclusive of the tactile electrode, is preferably made of a plastic suchas polyethylene, acrylonitrile, butadiene, styrene or similar durableplastic. The battery portion 24 is connected to a voltage multiplier 22which steps up the voltage supplied by the battery 24 and applies thestepped up voltage to the current driver 19. Current driver 19 presentsa defined current and voltage output at the application electrode 12 thevalue of the current, which may be empirically determined beingsufficient to drive the medicament through the porous, open-celledmaterial 27 (FIG. 2) within the application electrode interposed betweenthe skin contacting surface 13 and reservoir 26 containing the unit dosemedicament and penetrate the patient's skin. The circuitry limits themaximum current available to the application electrode to preferably toless than about one milliampere per two square centimeters of theskin-contacting surface area 13 of the application electrode 12.However, depending upon working electrode's 12 skin-contacting surface13 configuration, the current level can vary from about 0.1 to about 1.2milliamps. Currents ranging between 0.1 ma to 5 ma have been usedclinically by the present inventor, but the higher currents caused theuser minor discomfort and, with chronic use over time, may produceuntoward effects.

FIG. 2 shows a preferred embodiment of the iontophoreticmedicament-containing application electrode 12. The applicationelectrode 12 is preferably disposable and non-reusable and is suitable,for example, for transdermally delivering antiviral agents such asAcyclovir® for the treatment of cold sores or genital herpes. The sizeof the skin-contacting surface 13 of application electrode 12 may varyto accommodate specific clinical applications. The application electrode12 is detachably housed within a recess within the receptacle 14 whichrecess presents an electrically conductive interior surface to completethe electrical flow path from the connecting wires 18 and 16 to aconductive element 29 within the application electrode. The electricalcurrent from the current driver 19 is conducted through conductive innersurface of the application electrode receptacle 14 to the electricallyconductive element 29 within the applicator electrode which element 29is in electrical contact with the inner surface of the receptacle incontact therewith to drive the medicament 23 or treatment agent throughthe open-celled sponge-like matrix material 27 and through the user'sskin (not shown). The medicament or treatment agent 23 is containedwithin a rupturable polymer reservoir 26 until dispensed duringtreatment. A slight exertion of pressure or squeezing of the reservoir26 against reservoir puncture means 28 releases the medicament ortreatment agent into an open-celled sponge-like material 27 within theapplication electrode for iontophoretic delivery into the patient'sskin. Medicament 23 release can occur at the time of application or uponperuse compression of the electrode 12. Application electrode 12 can beadvantageously designed to include a stripping portion adapted so thatupon removal of the application electrode 12 from the electrodereceptacle 14 a protruding stripping portion (not shown) scrapinglystrips the conductive coating from the conductive support arm 29 toprevent reuse of the disposable electrode 12. Application electrode 12is intentionally packaged with a single dose packet or reservoir 26 oftreatment agent or medicament 23. In addition to the medicament, thereservoir 26 can include a coloring agent, such as iodine, which turnsdark blue upon contact with starch in the open-celled material tovisibly indicate that the unit dose encapsulation has been used. Othersuitable coloring agents can include pH indicators, wet saturationindicators or oxidizable pigments.

The open-celled sponge-like material 27 surrounding reservoir 26 shouldbe inert to the medicament or treatment agent being employed, as well asbeing non-corrosive and stable when in contact with the treatment agent.Suitable materials include plastic pads, such as polyethylene, paper orcotton, porous ceramics, open-celled porous polytetrafluoroethylene,polyurethane and other inert plastics, and open-celled silicone rubber,such as may be employed with vertically aligned medicament-containingtubes. A typical medicament that can be contained within the rupturablepolymer reservoir 26 is xylocaine or similar topical anesthetic.

The disposable electrode 12 possesses the advantages of preventingleaching or migration of the medicament from within the rupturablepolymer reservoir, no attendant loss of efficacy, a long shelf life andlittle or no electrode corrosion. A suitable electrical control circuitfor use in the iontophoretic medicament delivery apparatus 12 is shownin U.S. patent application, Ser. No. 07/579,799, filed Sep. 10, 1990,now U.S. Pat. No. 5,160,316 and hereby specifically incorporated byreference herein in pertinent part.

FIG. 3 shows a particularly preferred embodiment of a disposable,one-time use electrode 30 for use with the iontophoresis handpiece 10 ofthe present invention. FIG. 3 is a top view of the disposable electrode30 with the upper release film 41 (FIG. 4) removed. A non-conductivesubstrate 31 is formed into a flat strip having a central portion A andtwo end portions B. The end portions B each have a cut-out thereincontaining an electrically conductive gel 32. The gel 32 may be imbeddedwithin a mesh or it may be constrained within the cut out by means of aporous, non-wicking and non-electrically conducing containment layer 34and 35 much as tea is contained within a porous tea bag. The centralportion A of the strip 31 has a medicament-containing reservoir 33therewithin. The medicament-containing reservoir 33 may comprise asuitable medicament embedded within the mesh of a pharmacologicallyinert material. The medicament-containing reservoir 33 is positionedbetween die cuts 36 in the non-conductive substrate 31 which die cutsprovide means for facilitating the predictable bending the electrodestrip 30 to matingly conform to the shape of the exterior surface of aniontophoresis handpiece 10 (FIG. 1). Magnets 43 and 43' (shown inphantom in FIG. 3) disposed laterally to the central portion A providemeans for magnetically activating a handpiece when the electrode is inposition.

An exploded side view of the electrode 30 is shown in FIG. 4. Theconductive gel 32 filling the cut-outs may be contained within a mesh ormay be contained within the cut-out by means of porous, non-wickinglayers 34 and 35. Similarly, the medicament-containing cut-out 33 maycomprise the medicament embedded within a mesh, a gel, or similarsubstrate which releases the medicament in response to an electricalcommunication therewith. The upper containment layer 34 and the lowercontainment layer 35 serve to restrain the conductive gel within themedicament reservoir 33 to their respective cut-outs. An upper releasefilm 41 is used to protect the adhesive surface (not shown) on theuppermost surface of the containment layer 34. A lower release film 42serves a similar function to protect the adhesive surface of the lowermedicament containment layer 35. The cut-outs 36 are shown to penetratethe strip of non-conductive material 31 adjacent to themedicament-containing reservoir 33. It is particularly desirable toprovide one or more activating magnetic bodies 43 and 43' within thestrip 31 in order to properly position the electrode strip 30 andactivate the handpiece 10. Since it is anticipated that thehandpiece/electrode assembly of the present invention will most likelybe used in the bathroom, it is particularly desirable to hermeticallyseal the handpiece's internal operational mechanisms. The on/off switchwithin the handpiece can be in the form of a magnetically responsiveswitch which is turned "on" and "off" in response to the position of theelectrode.

Turning now to FIG. 5, we see a disposable electrode 30 in the processof being applied to the terminal end of an iontophoresis handpiece 10.The electrode 30 is applied to the active terminal 16 of the handpiecein such a manner that the medicament-containing reservoir 33 overliesand is in electrical contact with the active terminal 16 of thehandpiece 10. The conductive gel layers 32 are positioned on thehandpiece to overly the ground electrode on the handpiece 10. The groundelectrode is indicated at 20 in FIG. 5.

An alternate but equally effective embodiment of FIG. 4 electrode can bemanufactured from a mold injected soft, inert material, non-conductiveand non-porous (such as SILASTIC®- by Dow Corning) in the shape embodiedin FIG. 3. The unit will contain vertically aligned open cells forcontaining and acting as reservoir for therapeutic medicaments as wellas a conductive gel (if necessary). Such an embodiment is less costly toproduce and avoids the process of assembling numerous layers.

The iontophoresis handpiece and electrode assembly in accordance withthe preferred embodiment shown in FIGS. 3 and 4 is shown being used by apatient 60 in FIG. 6. The patient 60 grasps the handpiece by means ofplacing a finger 61 on at least one of the conductive gel groundelectrodes thereby grounding the patient's body. The active electrodedriver 19 of the handpiece is in electrical communication with themedicament-containing reservoir 33. The medicament-containing reservoir33, thus positioned and grasped by the patient, is advanced to come incontact with a lesion 63 on the patient's skin. Upon contact, electricalcurrent flows between the active electrode 19 in the handpiece to theground electrode(s) 32 via passage through the medicament-containingreservoir 33 comprising the active electrode. The polarity of thecurrent may be reversed to accommodate the charge on the medicament. Theflow of an electrical current facilitates entry of the medicament withinthe reservoir 33 into the skin overlying the lesion 63 thereby locallydelivering the medicament to the exact area to be treated.

EXPERIMENTAL CLINICAL TRIALS

The inventor has conducted a clinical study using a prototypeiontophoretic device in accordance with the present invention for thetreatment of cold sores. The clinical response was promising. A secondindependent, qualified investigator, a board-certified Urologist,conducted a study using the present apparatus and method for treatingmale genital herpes lesions with encouraging results. Table 1 summarizesdata (discussed below) supporting the claim to unexpected clinicalbenefits treating disease with this novel method. The method andmedicament application device when used together for treating thesecommon, embarrassing, and previously not easily-treatable ailmentsprovide surprising advantages.

The embodiment of the device shown in FIG. 1 and described hereinaboveis a improvement over the prototype used in the clinical study, whichwas a larger unit, not user friendly, which required physicallyconnecting wires to the patient's body which created anxiety, and couldnot be used without attending personnel. Notwithstanding design, theapparatus used in the clinical study summarized in Table 1 employedelectronics similar to the apparatus described herein and was used tooptimize the clinical performance of the embodiment 12 of the devicedescribed herein.

                  TABLE 1    ______________________________________    STAGE I TREATMENT RESULTS    RESPONSE   IUDR      ACYCLOVIR ®                                     TOTALS    ______________________________________    No response               1         1           2    Some response               1         3           4    Major response               26        42          68    ______________________________________

The study included a control situation wherein seven patients were foundwho had simultaneous concurrent herpes lesions at separate locations ontheir bodies. In each case one lesion was treated with iontophoreticapplication of antiviral agent (Acyclovir® or IUDR) and the other lesionwas treated in the standard method employed in the prior art comprisingrepeated topical application of the same antiviral agent. Theiontophoretically enhanced treated lesion received a single 10-15 minutetreatment. All iontophoretically treated lesions demonstrated resolutionin 24 hours and none of the unassisted topically treated lesionsdemonstrated a similar response. The results for the control group aresummarized in Table 2.

                  TABLE 2    ______________________________________    CONTROL GROUP RESULTS             No response                       Some resp.                                 Major resp.    ______________________________________    IUDR    Treated lesion               0           0         7    Control lesion               5           2         0    ACYCLOVIR ®    Treated lesion               0           0         1    Control lesion               1           0         0    ______________________________________

The clinical studies included patient volunteers with full informedconsent who suffered from recurrent cold sores. The study demonstratedgreatest treatment efficacy if the herpes lesion received iontophoretictreatment within 36 hours of lesion onset. The treatment incorporated anelectrode saturated with Acyclovir® ointment (ZOVIRAX®) or IUDR(STOXIL®) Ophthalmic drops as supplied by the manufacturer. Thus mountedAnodic electrode of the prototype system was used for a 10-15 minuteapplication directly to the lesion with the average current setting of0.2 ma-0.6 ma which was well tolerated by all patients.

The lesion was evaluated in 24 hours. In 92% of the iontophoreticallytreated cases (>70 lesions treated) a major response was noted. A majorresponse was categorized by resolution of pain in <6 hours and lesioncrusted and healing within 24 hours. The normal course of cold soresinvolves an average period of 10-12 days before resolution and healingoccurs. The present apparatus and clinical method for treatment ofmucocutaneous Herpes Simplex (type I and Type II) eruptions presentedherein have been described and performed with excellent results. Thisnovel user friendly apparatus in combination with the disclosed clinicaltreatment method presents a very effective new treatment for HerpesSimplex eruptions.

While the invention has been described above with references to specificembodiments thereof, it is apparent that many changes, modifications andvariations in the materials, arrangements of parts and steps can be madewithout departing from the inventive concept disclosed herein. Forexample an impregnated conductive gel can also be used to as medicamentcontaining medium to increase the physical stability and the tissueadhering characteristics of the electrode. Accordingly, the spirit andbroad scope of the appended claims is intended to embrace all suchchanges, modifications and variations that may occur to one of skill inthe art upon a reading of the disclosure. All patent applications,patents and other publication cited herein are incorporated by referencein their entirety.

What I claim is:
 1. A disposable medicament dispensing applicatorelectrode for an iontophoretic drug delivery device adapted for theself-administration of a medicament into a person's skin, said devicecomprising a base assembly having an active terminal adapted to receiveand make electrical contact with a detachable medicament dispensingapplicator electrode wherein said base assembly comprises; a case havingan elongate, substantially cylindrical outer surface having a size andshape adapted to be comfortably grasped within a person's hand andwherein at least a portion of said outer surface is a tactile electrodeformed of an electrically conductive material; and a bipolar electricalpower means having a first pole and a second pole; said electrical powermeans being enclosed within said case and wherein said first pole is inelectrical communication with said tactile electrode; wherein saidmedicament dispensing applicator electrode comprises: a modulecontaining a unit dose of medicament, an electrically conductive workingelectrode and means thereon adapted for releasably attaching saidapplicator electrode to said second pole of said electrical power meanswherein said applicator electrode further comprises an elongate stripconstructed of a substantially electrically non-conductive substratematerial, said strip having a central portion containing a medicament inan electrically conductive substrate and said strip having laterallysymmetric end portions having cutouts therewithin.
 2. The disposablemedicament dispensing applicator electrode of claim 1 wherein saidcutouts in said laterally symmetric end portions contain an electricallyconductive material.
 3. The disposable medicament dispensing applicatorelectrode of claim 2 wherein said electrically conductive material is agel.
 4. A disposable medicament dispensing applicator electrode for aniontophoretic drug delivery device adapted for the self-administrationof a medicament into a person's skin, said device comprising a baseassembly having an active terminal adapted to receive and makeelectrical contact with a detachable medicament dispensing applicatorelectrode wherein said base assembly comprises; a case having anelongate, substantially cylindrical outer surface having a size andshape adapted to be comfortably grasped within a person's hand andwherein at least a portion of said outer surface is a tactile electrodeformed of an electrically conductive material; and a bipolar electricalpower means having a first pole and a second pole; said electrical powermeans being enclosed within said case and wherein said first pole is inelectrical communication with said tactile electrode; wherein saidmedicament dispensing applicator electrode comprises: a modulecontaining a unit dose of medicament, an electrically conductive workingelectrode and means thereon adapted for releasably attaching applicatorworking electrode to said second pole of said electrical power meanswherein said applicator electrode further comprises an elongate stripconstructed of a substantially electrically non-conductive substratematerial, said strip having a central portion containing a medicament inan electrically conductive substrate and said strip having laterallysymmetric end portions having cutouts therewithin.